NEW YORK – China-based Hansoh Pharma said on Thursday that its drug almonertinib (Amelie, or HS-10296) has received marketing authorization from China's National Medical Products Administration (NMPA) for patients with EGFR T790-mutated non-small cell lung cancer that has progressed on or after EGFR tyrosine kinase inhibitor therapy.
Almonertinib is a third-generation EGFR TKI. Currently, EGFR mutations occur in 40 percent of NSCLC patients in China, and approximately half of NSCLC patients will develop a T790M mutation, which confers resistance to a first- or second-generation TKI.
Almonertinib'sregistrational study, APOLLO, was an open-label, single-arm Phase II trial involving 244 participants with recurrent NSCLC with EGFR T790M mutations. Investigators reported that patients taking the drug as a monotherapy had a median progression-free survival of 12.3 months and an overall response rate of 68.9 percent. The reported disease control rate was 93.4 percent. Additionally, it appeared to have a favorable safety profile.